The GRADE approach for assessing new technologies as applied to apheresis devices in ulcerative colitis

Ibargoyen-Roteta, Nora; Gutiérrez-Ibarluzea, Iñaki; Rico-Iturrioz, Rosa; López-Argumedo, Marta; Reviriego-Rodrigo, Eva; Cabriada-Nuño, Jose Luis; Schünemann, Holger J

doi:10.1186/1748-5908-5-48

Implementation Science

Table 2 GRADE evidence Profile for the first clinical question

From: The GRADE approach for assessing new technologies as applied to apheresis devices in ulcerative colitis

Quality assessment							Summary of findings					Importance
							No of patients		Effect		Quality
No of studies	Design	Limitations	Inconsistency	Indirectness	Imprecision	Other considerations	Apheresis systems	Corticosteroid treatment	Relative (95% CI)	Absolute
Clinical Remission one month after treatment (follow-up median 3 weeks)
3	randomised trial	serious¹	no serious inconsistency²	no serious indirectness³	serious⁴	none	42/62 (67.7%)	32/73 (43.8%)	RR 1.47 (1,07 to 2,02)	206 more per 1000 (from 31 fewer to 447 more)	⊕⊕OO LOW	CRITICAL
Endoscopic Remission one month after treatment (follow-up mean 1 weeks; range of scores: 0-0; Better indicated by less)
1	randomised trial	serious⁵	no serious inconsistency⁶	serious⁷	serious^4,6	none	20	20	-⁸	-⁸	⊕OOO VERY LOW	CRITICAL
Mild adverse effects of the treatment (follow-up median 3 weeks)
3	randomised trial	serious¹	serious⁹	no serious indirectness	serious^4,10	none	9/62 (14.5%)	22/73 (30.1%)	OR 0.50 (0.12 to 2.02)	135 fewer per 1000 (from 258 fewer to 209 more)	⊕OOO VERY LOW	IMPORTANT
Moderate to severe adverse effects (follow-up median 3 weeks)
2	randomised trial	serious¹¹	no serious inconsistency	no serious indirectness	serious⁴	none	0/29 (0%)	5/40 (12.5%)	OR 0.15 (0.02 to 1.27)	105 fewer per 1000 (from 122 fewer to 30 more)	⊕⊕OO LOW	CRITICAL
Clinical Remission 12 months after treatment - not measured
0	-	-	-	-	-	-	-	-	-	-		IMPORTANT

¹We don't know if these studies are blinded. In the study of Nishioka et al, patients were free to choose the treatment they wanted to receive (it was not really a randomized controlled trial); nevertheless, it was included in the meta-analysis, although the quality was downgraded here. One of the studies (Hanai et al, 2006) was an abstract, although we found the information we needed.
² The percentage of patients in remission was not consistent in the included studies, although we made a meta-analysis and found that the p for heterogeneity was 0.24. Therefore, we did not consider this issue important enough for downgrading.
³The clinical remission was defined as a Mayo Index from 0 to 2 points, but in the included studies, the CAI was used, sometimes in combination with the EI (Endoscopic Index).
⁴There is a small number of patients and a very small number of events (less than 300).
⁵This RCT is not blinded.
⁶There is only one study.
⁷There were no data about endoscopic remission, but there was information about the Mean Endoscopic Index for the intervention and control group, before and after the treatment. After the treatment, the mean EI fell 5.5 and 6 points for the apheresis and the corticosteroids groups respectively.
⁸We couldn't calculate it, but it seems that there is no difference between treatments.
⁹The results obtained by Nishioka et al, 2005, are not consistent with the other two included studies. In the meta-analysis, we found an I2 of 57% and we considered that this heterogeneity was important enough to downgrade.
¹⁰95% CI for the total effect is wide.
¹¹We don't know if included studies are blinded.

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ISSN: 1748-5908

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